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Determine the Safety and Dose of EN001 in Patients With Duchenne Muscular Dystrophy(DMD)

NCT05338099 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-08-30

No results posted yet for this study

Summary

Open-label, Dose-escalation, Phase 1 Clinical Trial to Determine the Safety and Dose of EN001 in Patients with Duchenne Muscular Dystrophy(DMD)

Conditions

Interventions

DRUG

EN001

EN001 intravenously (IV) in the treatment of Duchenne Muscular Dystrophy (DMD) Dosage for each group is as follows. Dose group A (Low dose): 5.0x10\^5 cells/kg

DRUG

EN001

EN001 intravenously (IV) in the treatment of Duchenne Muscular Dystrophy (DMD) Dosage for each group is as follows. Dose group B (High dose): 2.5x10\^6 cells/kg

Sponsors & Collaborators

  • ENCell

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-18
Primary Completion
2022-12-28
Completion
2022-12-28

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05338099 on ClinicalTrials.gov